Latest Developments Regulation Proposal - New Genomic Techniques

Back in July 2023, the European Commission adopted a proposal for a regulation on plants obtained by new genomic techniques (NGTs). This aims to stimulate innovation while maintaining safety standards, as part of the European Farm to Fork strategy.[1] On 14 March 2025, the Council’s mandate for negotiations with the European Parliament was endorsed, opening the door for interinstitutional negotiations. Businesses active in the agriculture and agritech sector and should proactively monitor the proposal’s progress. 

The current framework and the proposal 

NGT plants are currently still subject to the existing European framework governing traditional genetically modified organisms (GMOs).[2] According to a study of the European Commission from 2021 on the legal framework, the strict risk assessment requirements and authorisation procedure under the GMO legislation are inadequate for NGT plants. The European Commission came to the conclusion that the current legislative framework is considered outdated and must be revised to reflect current scientific and technological advancements.[3] It was clear that there was a need for new legislation to drive innovation forward. 

The current proposal aims to highlight the potential of NGTs to open new opportunities; enabling the rapid development of plant varieties with specific traits. The proposed regulation aims to ensure high levels of protection for human, animal, and environmental health and it seeks to enable the development and commercialisation of plants as well as products derived from NGT plants that, amongst others, contribute to the innovation and sustainability objectives of the European Green Deal. Additionally, it aims to ensure the effective functioning of the internal market for NGT plants and products, enhancing the competitiveness of the European agri-food sector while maintaining a level playing field.[4]

Two Types of NGT Plants 

One of the main elements of the proposal is the distinction between two categories of NGT plants, each with corresponding rules. In short, NGT plants considered equivalent to conventional plants, so-called ‘NGT 1 plants’, would be exempted from the requirements of the existing GMO legislation. These plants will require mandatory labelling for seeds and must be registered in a public online database. To qualify for this exemption, NGT 1 plants must differ by no more than 20 genetic modifications from the parent plant. 

For the remainder of the NGT plants, the so-called ‘NGT 2 plants’, this proposal applies the (strict) GMO legislative framework, including mandatory labelling and traceability requirements. To encourage their uptake, category 2 NGT plants will undergo an accelerated risk assessment procedure. All NGT plants will remain banned in organic farming, as further research is needed to determine their suitability for this purpose.[5] This legislative separation has been subject to serious discussions amongst the stakeholders, especially after the French Agency for Food, Environmental and Occupational Health & Safety published a scientific analysis on the proposed equivalence criteria, underling the need for clarification of, amongst others, the scientific basis of the criteria and considering the potential risks from NGT 1 plants.[6] This was then followed by a scientific opinion from the European Food Safety Agency, mandated by the European Parliament, generally confirming the scientific basis of the equivalence criteria.[7]

A Patent Ban on all NGT Plants 

Another important hurdle in the negotiations, also raising serious concerns within the industry, is on the patentability of NGT plants. The European Parliament adopted its position on the proposed NGT regulation incorporating significant amendments. The most controversial amendment was the introduction of a new provision addressing patentability, which proposes a complete ban on patents for NGT plants, plant materials, parts thereof, genetic information, and associated process characteristics. The European Parliament has meanwhile requested a report on the impact of patents on farmers’ and breeders’ access to plant reproductive material by June 2025. They have further provided a legislative proposal to update European intellectual property legislation.[8]

Severe concerns over the proposed patent ban exists, considering that it could hinder investment, innovation, and global competitiveness. It has also been noted that the ban raises potential conflicts with the European Patent Convention and EPO case law.

Developments of the legislative procedure 

The proposal has been under discussion  in the Council of the EU for quite some time. Under the former Spanish and Belgian presidency, already two compromise texts had been put forward. Patentability of NGT plants was – and still is – a highly scrutinized topic in the discussions. In addition, Hungary – which held the rotating presidency last year - suggested expanding discussions to include labelling, controls, and equivalence criteria.[9] At the very end of last year, on 9 and 10 December 2024 the Hungarian presidency provided an update on the state of play of the proposal during the Agriculture and Fisheries Council meeting.[10] From this update, it clearly followed that several major topics were still under debate. 

At the beginning of 2025, the Polish presidency commenced, bringing this proposal again under a new presidency. The Polish Presidency presented a further adjusted text on 21 February 2025. With the introduced revisions, the Polish presidency aims to increase the level of transparency regarding patents on NGT Plants, encourage licensing on equitable conditions and assist operators in navigating the plant intellectual property landscape.[11] On 14 March 2025, the Permanent Representatives Committee reached a qualified majority on a Council’s mandate for the negotiations with the European parliament.[12]

The main elements of the Commission’s proposal with regard to the two types of NGT plants, are supported by the Council. However, they have also introduced several changes in the negotiating mandate. In particular, under the negotiating mandate Member States can opt out of cultivating category 2 NGT plants and implement measures to prevent their unintended presence in other products and cross-border contamination.[13] Moreover, for category 1 NGT plants, measures can be adopted to avoid their presence in organic farming, especially in specific geographical areas.[14]

The position of the Council with regard to patenting of NGTs clearly differs from the position of the European Parliament. The patent ban as adopted by the European Parliament, is not included in the negotiating mandate. Instead, the focus is on transparency regarding patents on NGT plants and encouraging licensing on equitable conditions. To that end, under the text of the negotiating mandate, requesters of a declaration of category 1 NGT plant status must provide information on existing or pending patents for category 1 NGT plants, which will be included in a publicly accessible database to ensure transparency.[15] Requesters may also submit a declaration of the patent holder confirming its willingness to license the protected subject under equitable conditions.[16] In addition, the negotiating mandate prescribes the establishment of a patenting expert group to assess the effects of patents, and a study to be conducted by the Commission on the impact of patenting as well as related licensing and transparency practices on innovation, seed availability, and competitiveness in the EU plant breeding sector.[17] Any follow-up measures or legislative proposals may be made based on the study's findings.

Furthermore, in accordance with the negotiating mandate, if the labelling of category 2 NGT plants mentions the traits conveyed by genetic modification, the labelling must cover comprehensive information on all modified traits to ensure consumer awareness.[18] Besides, the negotiating mandate includes a provision that herbicide tolerance cannot be a trait for category 1 NGT plants, ensuring these plants remain subject to stricter regulatory requirements of category 2 NGT plants.[19]

On 8 April 2025, the European Parliament’s Committee on Environment, Food Safety and Public Health (ENVI) voted in favour of opening interinstitutional negotiations between the Commission, Parliament and Council.[20] These negotiations are expected to commence in the coming months. Given the divergent positions on crucial points, it is important to of keep a close watch on these negotiations and the developments on a European level, especially given the far-reaching consequences this upcoming legislation will have for the industry, including the overall competitiveness. 

[1] Proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (COM(2023) 411 final).

[2] Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC.

[3] ‘Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16, SWD(2021) 92 final, 29 April 2021. 

[4] Proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (COM(2023) 411 final), para. 1. 

[5] Proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (COM(2023) 411 final). See also: Carriages preview | Legislative Train Schedule .

[6] OPINION of the French Agency for Food, Environmental and Occupational Health & Safety on the scientific analysis of Annex I of the European Commission’s Proposal for a Regulation of 5 July 2023 on new genomic techniques (NGTs) – Review of the proposed equivalence criteria for defining category 1 NGT plants, 29 November 2023 (https://www.anses.fr/fr/system/files/BIOT2023AUTO0189EN.pdf).

[7] Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178)(Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178) - - 2024 - EFSA Journal - Wiley Online Library).

[8] Amendments adopted by the European Parliament on 7 February 2024 on the proposal for a regulation of the European Parliament and of the Council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625 (P9_TA(2024)0067). See also: Carriages preview | Legislative Train Schedule

[9] Legislative Train 11 2024 | A European Green Deal | Plants produced by certain new genomic techniques.

[10] Council of the European Union, Information from the Presidency, 5 December 2024 (16254/24).

[11] Council of the European Union, Mandate for negotiations with the European Parliament, 7 March 2025 (6426/25), p. 3-4.

[12] Council of the EU, ‘New genomic techniques: Council agrees negotiating mandate’, 14 March 2025, see https://www.consilium.europa.eu/en/press/press-releases/2025/03/14/new-genomic-techniques-council-agrees-negotiating-mandate/

[13] Recital 37 of the text to be used as the mandate for negotiations with the European Parliament.

[14] Recital 24 of the text to be used as the mandate for negotiations with the European Parliament.

[15] Articles 6(3x), 7(2x) and 9, and recitals 16 and 21 of the text to be used as the mandate for negotiations with the European Parliament.

[16] Articles 6(3xx) and 7(2xx) of the text to be used as the mandate for negotiations with the European Parliament.

[17] Article 30bis and recital 46a of the text to be used as the mandate for negotiations with the European Parliament.

[18] Article 23 and recital 32 of the text to be used as the mandate for negotiations with the European Parliament.

[19] Article 3(7)(a) and recital 14ter of the text to be used as the mandate for negotiations with the European Parliament.

[20] Legislative Observatory, 2023/0226(COD), Plants obtained by certain new genomic techniques and their food and feed. Also see European parliament Committee on Environment, Food Safety and Public Health, Result of roll-call votes 8 April 2025, p. 3, https://www.europarl.europa.eu/cmsdata/294724/2025-04-08%20votes.pdf.